Unraveling patients' readiness in advance care planning conversations: a qualitative study as part of the ACTION Study.

PURPOSE: Patients' readiness for advance care planning (ACP) is often considered a prerequisite for starting ACP conversations. Healthcare professionals' uncertainty about patients' readiness hampers the uptake of ACP in clinical practice. This study aims To determine how patients' readiness is expressed and develops throughout an ACP conversation. METHODS: A qualitative sub-study into the ACTION ACP conversations collected as part of the international Phase III multicenter cluster-randomized clinical trial. A purposeful sample was taken of ACP conversations of patients with advanced lung or colorectal cancer who participated in the ACTION study between May 2015 and December 2018 (n = 15). A content analysis of the ACP conversations was conducted. RESULTS: All patients (n = 15) expressed both signs of not being ready and of being ready. Signs of being ready included anticipating possible future scenarios or demonstrating an understanding of one's disease. Signs of not being ready included limiting one's perspective to the here and now or indicating a preference not to talk about an ACP topic. Signs of not being ready occurred more often when future-oriented topics were discussed. Despite showing signs of not being ready, patients were able to continue the conversation when a new topic was introduced. CONCLUSION: Healthcare professionals should be aware that patients do not have to be ready for all ACP topics to be able to participate in an ACP conversation. They should be sensitive to signs of not being ready and develop the ability to adapt the conversation accordingly.

Content analysis of Advance Directives completed by patients with advanced cancer as part of an Advance Care Planning intervention: insights gained from the ACTION trial.

PURPOSE: Writing an Advance Directive (AD) is often seen as a part of Advance Care Planning (ACP). ADs may include specific preferences regarding future care and treatment and information that provides a context for healthcare professionals and relatives in case they have to make decisions for the patient. The aim of this study was to get insight into the content of ADs as completed by patients with advanced cancer who participated in ACP conversations. METHODS: A mixed methods study involving content analysis and descriptive statistics was used to describe the content of completed My Preferences forms, an AD used in the intervention arm of the ACTION trial, testing the effectiveness of the ACTION Respecting Choices ACP intervention. RESULTS: In total, 33% of 442 patients who received the ACTION RC ACP intervention completed a My Preferences form. Document completion varied per country: 10.4% (United Kingdom), 20.6% (Denmark), 29.2% (Belgium), 41.7% (the Netherlands), 61.3% (Italy) and 63.9% (Slovenia). Content analysis showed that 'maintaining normal life' and 'experiencing meaningful relationships' were important for patients to live well. Fears and worries mainly concerned disease progression, pain or becoming dependent. Patients hoped for prolongation of life and to be looked after by healthcare professionals. Most patients preferred to be resuscitated and 44% of the patients expressed maximizing comfort as their goal of future care. Most patients preferred 'home' as final place of care. CONCLUSIONS: My Preferences forms provide some insights into patients' perspectives and preferences. However, understanding the reasoning behind preferences requires conversations with patients.

Trained facilitators' experiences with structured advance care planning conversations in oncology: an international focus group study within the ACTION trial.

BACKGROUND: In oncology, Health Care Professionals often experience conducting Advance Care Planning (ACP) conversations as difficult and are hesitant to start them. A structured approach could help to overcome this. In the ACTION trial, a Phase III multi-center cluster-randomized clinical trial in six European countries (Belgium, Denmark, Italy, the Netherlands, Slovenia, United Kingdom), patients with advanced lung or colorectal cancer are invited to have one or two structured ACP conversations with a trained facilitator. It is unclear how trained facilitators experience conducting structured ACP conversations. This study aims to understand how facilitators experience delivering the ACTION Respecting Choices (RC) ACP conversation. METHODS: A qualitative study involving focus groups with RC facilitators. Focus group interviews were recorded, transcribed, anonymized, translated into English, and thematically analysed, supported by NVivo 11. The international research team was involved in data analysis from initial coding and discussion towards final themes. RESULTS: Seven focus groups were conducted, involving 28 of in total 39 trained facilitators, with different professional backgrounds from all participating countries. Alongside some cultural differences, six themes were identified. These reflect that most facilitators welcomed the opportunity to participate in the ACTION trial, seeing it as a means of learning new skills in an important area. The RC script was seen as supportive to ask questions, including those perceived as difficult to ask, but was also experienced as a barrier to a spontaneous conversation. Facilitators noticed that most patients were positive about their ACTION RC ACP conversation, which had prompted them to become aware of their wishes and to share these with others. The facilitators observed that it took patients substantial effort to have these conversations. In response, facilitators took responsibility for enabling patients to experience a conversation from which they could benefit. Facilitators emphasized the need for training, support and advanced communication skills to be able to work with the script. CONCLUSIONS: Facilitators experienced benefits and challenges in conducting scripted ACP conversations. They mentioned the importance of being skilled and experienced in carrying out ACP conversations in order to be able to explore the patients' preferences while staying attuned to patients' needs. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number registry 63110516 ( ISRCTN63110516 ) per 10/3/2014.

Responsible data sharing in a big data-driven translational research platform: lessons learned.

BACKGROUND: To foster responsible data sharing in health research, ethical governance complementary to the EU General Data Protection Regulation is necessary. A governance framework for Big Data-driven research platforms will at least need to consider the conditions as specified a priori for individual datasets. We aim to identify and analyze these conditions for the Innovative Medicines Initiative's (IMI) BigData@Heart platform. METHODS: We performed a unique descriptive case study into the conditions for data sharing as specified for datasets participating in BigData@Heart. Principle investigators of 56 participating databases were contacted via e-mail with the request to send any kind of documentation that possibly specified the conditions for data sharing. Documents were qualitatively reviewed for conditions pertaining to data sharing and data access. RESULTS: Qualitative content analysis of 55 relevant documents revealed overlap on the conditions: (1) only to share health data for scientific research, (2) in anonymized/coded form, (3) after approval from a designated review committee, and while (4) observing all appropriate measures for data security and in compliance with the applicable laws and regulations. CONCLUSIONS: Despite considerable overlap, prespecified conditions give rise to challenges for data sharing. At the same time, these challenges inform our thinking about the design of an ethical governance framework for data sharing platforms. We urge current data sharing initiatives to concentrate on: (1) the scope of the research questions that may be addressed, (2) how to deal with varying levels of de-identification, (3) determining when and how review committees should come into play, (4) align what policies and regulations mean by "data sharing" and (5) how to deal with datasets that have no system in place for data sharing.

Narrative medicine as a medical education tool: A systematic review.

Aim: Narrative medicine has been promoted as an innovative and effective means of stimulating medical students' professional development by teaching them to approach their patients' experiences of illness with more understanding and compassion. This systematic literature review aims to answer the following question: what evidence of effect is available in the literature about models for teaching narrative medicine? Methods: We conducted a narrative review of 36 articles and used the Best Evidence in Medical Education (BEME) Global Scale and Kirkpatrick Scale for strength and importance of evidence to categorize reported assessment strategies and to evaluate the effectiveness of their narrative medicine programs. Results: We found evidence that narrative medicine is an effective pedagogic tool with a clear and replicable structure and methodology. We also determined that a positive impact could be measured when pertaining to participation and modification of attitudes, knowledge, and skills. However, unequivocal evidence of the effect of narrative medicine on students' behavior or ongoing interaction with colleagues and patients is still lacking. Conclusion: While many recent publications describe the goals and virtues of a narrative-based approach, more research is needed to determine whether or not there is an ideological consensus undergirding this approach. In addition, it is still unclear whether the long-term impact of narrative medicine classroom interventions are felt by patients, or whether such interventions positively impact patient care.

[Euthanasia of Dutch psychiatric patients in 2015-2017]. / Euthanasie van Nederlandse psychiatrische patiënten in 2015-2017.

BACKGROUND: The Netherlands is one of the few countries in the world that allows euthanasia and assisted suicide (EAS) due to psychiatric suffering. METHODS In 2015-2017 the Dutch regional euthanasia review committees published 43 case summaries online. Of these, 35 were suitable for analysis regarding patient characteristics and physician involvement, and 3 cases were described in detail.
RESULTS: In total, 77% of the patients were women and 51% were aged 50-70 years. Major depression disorder and personality disorders were present in almost half of the patients. All patients were considered mentally competent. CONCLUSIONS Although the incidence of psychiatric EAS cases is rising, we found no shift in patient characteristics. The division between psychiatric and somatic suffering may prove more complicated than expected. Patients dying from suicide differ in various ways from patients dying through EAS. The fact that all patients are considered competent could mean that they are unjustly seen as being vulnerable or that the competence assessment lacks due diligence.

Perspective; recommendations for improved patient participation in decision-making for geriatric patients in acute surgical settings.

Geriatric patients often present to the hospital in acute surgical settings. In these settings, shared decision-making as equal partners can be challenging. Surgeons should recognize that geriatric patients, and frail patients in particular, may sometimes benefit from de-escalation of care in a palliative setting rather than curative treatment. To provide more person-centred care, better strategies for improved shared decision-making need to be developed and implemented in clinical practice. A shift in thinking from a disease-oriented paradigm to a patient-goal-oriented paradigm is required to provide better person-centred care for older patients. We may greatly improve the collaboration with patients if we move parts of the decision-making process to the pre-acute phase. In the pre-acute phase appointing legal representatives, having goals of care conversations, and advance care planning can help give physicians an idea of what is important to the patient in acute settings. When making decisions as equal partners is not possible, a greater degree of physician responsibility may be appropriate. Physicians should tailor the "sharedness" of the decision-making process to the needs of the patient and their family.

[Heart donation after circulatory death: ethical and emotional aspect of central normothermic regional perfusion]. / Hoe behoud je een donorhart na circulatoir overlijden?

Heart transplantation after circulatory death is possible in different countries with the use of ex situ normothermic perfusion of the donor heart. Central normothermic regional perfusion, where the circulation in the donor is restarted using an extracorporeal life support system after circulatory death, may give a better 1-years survival and a reduction in costs compared to ex situ normothermic perfusion of the donor heart. However, restarting circulation in a donor that was just declared death by circulatory criteria may be controversial. The advantages described are, in our view, reason to consider central normothermic regional perfusion, in which case a debate on ethical and emotional aspects is of great importance. In this article, we describe two point of views and hope in this way to start the debate on central normothermic regional perfusion in the Netherlands.

[Discussing the resuscitation policy at a geriatric ward: the experience of patients or their representatives]. / Bespreken van het reanimatiebeleid op een afdeling geriatrie: de ervaring van patiënt en familie.

AIM: To identify geriatric patients' and their surrogate decision makers' experience with regard to discussing cardio pulmonary resuscitation (CPR) policy. METHODS: This is a prospective, observational, explorative survey. During 10 weeks, all patients admitted to a geriatric ward of a general Dutch hospital or their representatives were asked for their experience regarding discussion of the resuscitation policy with the physician in attendance. Discussing this policy is a standard procedure at the first day of admission. We also asked on several factors which could influence their experience and on factors to improve discussing resuscitation policies. The primary outcome was the participant's satisfaction expressed on a scale of 1 to l0 regarding satisfaction with the CPR discussion. RESULTS: Seventy-six participants were included, of which 29 patients and 47 surrogate decision makers. Discussing the resuscitation policy took an average of 4,5 minutes (SD 3.2) to complete. In 70% (n=53) of cases a do-not-resuscitate decision was made. Discussing the resuscitation policy was experienced positive, with an average rate of 7,8 (SD 1.5). A total of 121 positive comments were made, as opposed to 70 negative comments. When they talked about their resuscitation policy, most patients expressed positive emotional responses. As most important improvements were mentioned: a better introduction to discussing this subject (17%), a better explanation of resuscitation and chances of survival (17%) and providing information prior to admission to the ward, so that patient and surrogate decision maker have been informed that the resuscitation policy will be discussed (12%). CONCLUSION: Most patients and relatives in this study wished to discuss their resuscitation policy with physicians. Still, there is room for improvement in several respects. Patients and surrogate decision makers are in favour of discussing the standard resuscitation policy with the doctor, and evaluate this conversation with a 7.8 / 10. In order to improve both discussing the CPR policy preparing the patient and his representatives and communicating more extensively during the interview are recommended.

Physicians' labelling of end-of-life practices: a hypothetical case study.

OBJECTIVES: To investigate why physicians label end-of-life acts as either 'euthanasia/ending of life' or 'alleviation of symptoms/palliative or terminal sedation', and to study the association of such labelling with intended reporting of these acts. METHODS: Questionnaires were sent to a random, stratified sample of 2100 Dutch physicians (response: 55%). They were asked to label six hypothetical end-of-life cases: three 'standard' cases and three cases randomly selected (out of 47), that varied according to (1) type of medication, (2) physician's intention, (3) type of patient request, (4) patient's life expectancy and (5) time until death. We identified the extent to which characteristics of cases are associated with physician's labelling, with multilevel multivariable logistic regression. RESULTS: The characteristics that contributed most to labelling cases as 'euthanasia/ending of life' were the administration of muscle relaxants (99% of these cases were labelled as 'euthanasia/ending of life') or disproportional morphine (63% of these cases were labelled accordingly). Other important factors were an intention to hasten death (54%) and a life expectancy of several months (46%). Physicians were much more willing to report cases labelled as 'euthanasia' (87%) or 'ending of life' (56%) than other cases. CONCLUSIONS: Similar cases are not uniformly labelled. However, a physicians' label is strongly associated with their willingness to report their acts. Differences in how physicians label similar acts impede complete societal control. Further education and debate could enhance the level of agreement about what is physician-assisted dying, and thus should be reported, and what not.

Deciding about continuous deep sedation: physicians' perspectives: a focus group study.

Although guidelines restrict the use of continuous deep sedation to patients with refractory physical symptoms and a short life-expectancy, its use is not always restricted to these conditions. A focus group study of physicians was conducted to gain more insight in the arguments for and against the use of continuous deep sedation in several clinical situations. Arguments in favour of continuous deep sedation for patients with a longer life-expectancy were that the overall clinical situation is more relevant than life-expectancy alone, and that patients' wishes should be followed. Continuous deep sedation for patients with predominantly emotional/existential suffering was considered appropriate when physicians empathize with the suffering. Further, some physicians indicated that they may consider the use of sedation in the context of a euthanasia request. Arguments were that the option of continuous deep sedation is a better alternative; it may comfort some patients when their thoughts about potential future suffering become unbearable. Further, some considered continuous deep sedation as less burdening or a bother to perform. We conclude that physicians' decision-making about continuous deep sedation is characterized by balancing the interests of patients with their own feelings. Accordingly, the reasons for its use are not unambiguous and need further debate.

Can we justify eliminating coercive measures in psychiatry?

The practice of coercive measures in psychiatry is controversial. Although some have suggested that it may be acceptable if patients are a danger to others or to themselves, others committed themselves to eliminate it. Ethical, legal and clinical considerations become more complex when the mental incapacity is temporary and when the coercive measures serve to restore autonomy. We discuss these issues, addressing the conflict between autonomy and beneficence/non-maleficence, human dignity, the experiences of patients and the effects of coercive measures. We argue that an appeal to respect autonomy and/or human dignity cannot be a sufficient reason to reject coercive measures. All together, these ethical aspects can be used both to support and to reject a non-seclusion approach. The total lack of controlled trials about the beneficial effects of coercive measures in different populations however, argues against the use of coercive measures.

The justificatory power of moral experience.

A recurrent issue in the vast amount of literature on reasoning models in ethics is the role and nature of moral intuitions. In this paper, we start from the view that people who work and live in a certain moral practice usually possess specific moral wisdom. If we manage to incorporate their moral intuitions in ethical reasoning, we can arrive at judgements and (modest) theories that grasp a moral experience that generally cannot be found outside the practice. Reflective equilibrium (RE) provides a framework for balancing moral intuitions, ethical principles and general theories. Nevertheless, persisting problems associated with the use of intuitions need to be addressed. One is the objection that moral intuitions lack the credibility necessary to guide moral reasoning. Ethicists have tried to solve this problem by formulating criteria to separate the "bad" intuitions from the "good" ones at the beginning of the reasoning process. We call this the credible input-justified outcome strategy. An example is the appeal to the common morality by Beauchamp and Childress. We think this approach is unsuccessful. As an alternative, we outline the good reasoning-justified outcome strategy. It connects to a variant of RE in which intuitions from different sources are incorporated. We argue that the elements of RE have different levels of justificatory power at the start of reasoning. In our strategy, each element can gain or lose justificatory power when it is tested in a reasoning process that meets several criteria.

[The option of non-treatment as part of end-of-life care]. / Doorbehandelen tot de dood erop volgt?

In this article we describe the story of a patient who died aged 63 as a result of pancreatic cancer. In the 14 weeks between diagnosis and passing away, at no point was it discussed whether treatment was in the patient's interest at such an advanced stage of the disease. The topic of death was not broached either. We wish to encourage doctors to consider a treatment option that seems to be a delicate topic of conversation for both doctor and patient: the option of non-treatment. It is necessary for doctors to make end-of-life discussions less daunting. The art of medicine does not necessarily consist of following a protocol; rather, the medical knowledge contained in that protocol should be drawn from, in order to serve the patient's objectives.

Ethics in clinical trial regulation: ethically relevant issues from EMA inspection reports.

BACKGROUND: Within the EU, regulators are obliged to take ethical issues into consideration during marketing authorization deliberation. The goal of this manuscript is to identify what kinds of ethical issues regulators encounter during marketing authorization application deliberations, and the incidence of these ethical issues. METHODS: This study used an EMA-provided Excel file that contains all the GCP non-compliance findings from all inspection reports from 2008-2012. There were 112 medicinal products and a total of 288 clinical trial sites. There were a total of 4014 GCP non-compliance findings. The findings that were ethically relevant were extracted using NVivo 10.0 and categories for the ethically relevant findings (ERFs) were created. Note was taken of the incidence of ERFs for each category and the inspectors' gradings of these findings were extracted. This study also looked at the mean and the maximum number of ERFs per grading per medicinal product application, as well as the number of medicinal products with at least one ERF and those with at least major ERFs. RESULTS: With multiple coding, there were 1685 ERFs. ERFs were present in almost all of the medicinal products (97.3%). The majority of ERFs were graded as major. At least major ERFs were present in almost all medicinal products with ERFs. The categories with the highest number of ERFs were protocol issues, patient safety, and professionalism issues. In terms of the density of combined critical and major findings, monitoring and oversight, protocol issues, and respect for persons top the list. This study also showed that, on average, there were 7.54 major and 2.95 critical ERFs per medicinal product application, although ERFs can increase to 30 major and 12 critical. CONCLUSION: Regulators regularly encounter ERFs that at least "might adversely affect the rights, safety or well-being of the subjects". It remains to be explored how regulators respond to these ethical issues.

Dutch criteria of due care for physician-assisted dying in medical practice: a physician perspective.

INTRODUCTION: The Dutch Euthanasia Act (2002) states that euthanasia is not punishable if the attending physician acts in accordance with the statutory due care criteria. These criteria hold that: there should be a voluntary and well-considered request, the patient's suffering should be unbearable and hopeless, the patient should be informed about their situation, there are no reasonable alternatives, an independent physician should be consulted, and the method should be medically and technically appropriate. This study investigates whether physicians experience problems with these criteria in medical practice. METHODS: In 2006, questionnaires were sent to a random, stratified sample of 2100 Dutch physicians (response rate: 56%). Physicians were asked about problems in their decision-making related to requests for euthanasia or assisted suicide after enforcement of the 2002 Euthanasia Act. RESULTS: Of all physicians who had received a request for euthanasia or assisted suicide (75%), 25% had experienced problems in the decision-making with regard to at least one of the criteria of due care. Physicians who had experienced problems mostly indicated to have had problems related to evaluating whether or not the patient's suffering was unbearable and hopeless (79%) and whether or not the patient's request was voluntary or well considered (58%). DISCUSSION: Physicians in The Netherlands most frequently reported problems related to aspects in which they have to evaluate the patient's subjective perspective(s). However, it can be questioned whether placing emphasis on these subjective aspects is an adequate fulfilment of the duties imposed on physicians, as laid down in the Dutch Euthanasia Act.